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Randomised clinical trial

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https://www.readbyqxmd.com/read/28225186/randomised-clinical-trial-the-efficacy-and-safety-of-oltipraz-a-liver-x-receptor-alpha-inhibitory-dithiolethione-in-patients-with-non-alcoholic-fatty-liver-disease
#1
W Kim, B G Kim, J S Lee, C K Lee, J E Yeon, M S Chang, J H Kim, H Kim, S Yi, J Lee, J-Y Cho, S G Kim, J-H Lee, Y J Kim
BACKGROUND: Oltipraz is a synthetic dithiolethione with an antisteatotic effect by inhibiting the activity of liver X receptor alpha (LXR-α). Recent studies demonstrated the disruptive role of oltipraz on LXR-α-dependent lipogenesis in hepatocytes and a high-fat diet mouse model. AIM: To evaluate the efficacy and safety of oltipraz for reducing liver fat in subjects with non-alcoholic fatty liver disease (NAFLD). METHODS: We performed a multicentre, double-blind, placebo-controlled, phase II study...
February 22, 2017: Alimentary Pharmacology & Therapeutics
https://www.readbyqxmd.com/read/28225050/impact-of-baseline-vitamin-b12-status-on-the-effect-of-vitamin-b12-supplementation-on-neurologic-function-in-older-people-secondary-analysis-of-data-from-the-open-randomised-controlled-trial
#2
L M Miles, E Allen, R Clarke, K Mills, R Uauy, A D Dangour
BACKGROUND/OBJECTIVES: The available evidence from randomised controlled trials suggests that vitamin B12 supplementation does not improve neurologic function in older people with marginal but not deficient Vitamin B12 status. This secondary analysis used data from the Older People and Enhanced Neurological function (OPEN) randomised controlled trial to assess whether baseline vitamin B12 status or change in vitamin B12 status over 12 months altered the effectiveness of dietary vitamin B12 supplementation on neurologic function in asymptomatic older people with depleted vitamin B12 status at study entry...
February 22, 2017: European Journal of Clinical Nutrition
https://www.readbyqxmd.com/read/28223259/use-of-an-antiepileptic-drug-to-control-epileptic-seizures-associated-with-cranioplasty-a-randomised-controlled-trial
#3
Fei Chen, Yaqi Duan, Yongqin Li, Wenjie Han, Weilei Shi, Weiwei Zhang, Yonghua Huang
BACKGROUND: Epilepsy is a common complication of cranioplasty. The present study was designed to explore the clinical effect of prophylactic anti-epilepsy drugs (AED) to control epileptic seizures associated with cranioplasty. METHODS: and design: This trial was a prospective, randomized, open-label, single-centre, active controlled study designed to investigate the use of antiepileptic drug to control epileptic seizures associated with cranioplasty. We tested the necessity and methods of drug use...
February 18, 2017: International Journal of Surgery
https://www.readbyqxmd.com/read/28222778/sample-size-considerations-for-trials-using-cerebral-white-matter-hyperintensity-progression-as-an-intermediate-outcome-at-1%C3%A2-year-after-mild-stroke-results-of-a-prospective-cohort-study
#4
Francesca M Chappell, Maria Del Carmen Valdés Hernández, Stephen D Makin, Kirsten Shuler, Eleni Sakka, Martin S Dennis, Paul A Armitage, Susana Muñoz Maniega, Joanna M Wardlaw
BACKGROUND: White matter hyperintensities (WMHs) are commonly seen on in brain imaging and are associated with stroke and cognitive decline. Therefore, they may provide a relevant intermediate outcome in clinical trials. WMH can be measured as a volume or visually on the Fazekas scale. We investigated predictors of WMH progression and design of efficient studies using WMH volume and Fazekas score as an intermediate outcome. METHODS: We prospectively recruited 264 patients with mild ischaemic stroke and measured WMH volume, Fazekas score, age and cardiovascular risk factors at baseline and 1 year...
February 21, 2017: Trials
https://www.readbyqxmd.com/read/28222702/the-virological-durability-of-first-line-art-among-hiv-positive-adult-patients-in-resource-limited-settings-without-virological-monitoring-a-retrospective-analysis-of-dart-trial-data
#5
David I Dolling, Ruth L Goodall, Michael Chirara, James Hakim, Peter Nkurunziza, Paula Munderi, David Eram, Dinah Tumukunde, Moira J Spyer, Charles F Gilks, Pontiano Kaleebu, David T Dunn, Deenan Pillay
BACKGROUND: Few low-income countries have virological monitoring widely available. We estimated the virological durability of first-line antiretroviral therapy (ART) after five years of follow-up among adult Ugandan and Zimbabwean patients in the DART study, in which virological assays were conducted retrospectively. METHODS: DART compared clinically driven monitoring with/without routine CD4 measurement. Annual plasma viral load was measured on 1,762 patients. Analytical weights were calculated based on the inverse probability of sampling...
February 21, 2017: BMC Infectious Diseases
https://www.readbyqxmd.com/read/28222546/recovering-functional-independence-after-a-stroke-through-modified-constraint-induced-therapy
#6
A Doussoulin, M Arancibia, J Saiz, A Silva, M Luengo
BACKGROUND: Population ageing and changes in the epidemiological profile of neurological pathologies has resulted in an increase in patients with disabilities. Rehabilitation strategies such as Modified Constraint-Induced Movement Therapy (CIMTm) play a key role in treating patients with neurologic deficiencies and motor impairments. This intervention is intended to mitigate disability, promote maximum functional independence, and optimize social and economic participation of patients with upper extremity weakness...
January 31, 2017: NeuroRehabilitation
https://www.readbyqxmd.com/read/28222250/long-term-treatment-of-cancer-associated-thrombosis-the-choice-of-the-optimal-anticoagulant
#7
REVIEW
I Elalamy, I Mahé, W Ageno, G Meyer
Patients with cancer associated thrombosis (CAT) carry a higher risk of recurrence, bleeding and mortality as compared to non-cancer patients. The specific profile of cancer patients combining frequent co-morbidities, the use of anti-tumoral therapies and the cancer progression itself represent a major therapeutic challenge for choosing a long-term anticoagulant treatment. This review discusses the practical basis of that choice among available drugs for the long-term antithrombotic strategy linked to their pharmacology, mechanism of action, evidence of clinical benefits, advantages and limitations in such a complex clinical context...
February 21, 2017: Journal of Thrombosis and Haemostasis: JTH
https://www.readbyqxmd.com/read/28222072/discrepancies-in-central-review-re-testing-of-patients-with-er-positive-and-her2-negative-breast-cancer-in-the-optima-prelim-randomised-clinical-trial
#8
S E Pinder, A F Campbell, J M S Bartlett, A Marshall, D Allen, M Falzon, J A Dunn, A Makris, L Hughes-Davies, R C Stein
BACKGROUND: There is limited data on results of central re-testing of samples from patients with invasive breast cancer categorised in their local hospital laboratories as oestrogen receptor (ER) positive and human epidermal growth factor receptor homologue 2 (HER2) negative. METHODS: The Optimal Personalised Treatment of early breast cancer usIng Multiparameter Analysis preliminary study (OPTIMA prelim) was the feasibility phase of a randomised controlled trial to validate the use of multiparameter assay-directed chemotherapy decisions in the UK National Health Service (NHS)...
February 21, 2017: British Journal of Cancer
https://www.readbyqxmd.com/read/28221665/totally-percutaneous-versus-surgical-cut-down-femoral-artery-access-for-elective-bifurcated-abdominal-endovascular-aneurysm-repair
#9
REVIEW
Madelaine Gimzewska, Alexander Ir Jackson, Su Ern Yeoh, Mike Clarke
BACKGROUND: Abdominal aortic aneurysms (AAAs) are a vascular condition with significant risk attached, particularly if they rupture. It is, therefore, critical to identify and repair these as an elective procedure before they rupture and require emergency surgery. Repair has traditionally been an open surgical technique that required a large incision across the abdomen. Endovascular abdominal aortic aneurysm repairs (EVARs) are now a common alternative. In this procedure, the common femoral artery is exposed via a cut-down approach and a graft introduced to the aneurysm in this way...
February 21, 2017: Cochrane Database of Systematic Reviews
https://www.readbyqxmd.com/read/28221205/muscle-relaxation-for-tracheal-intubation-during-paediatric-anaesthesia-a-meta-analysis-and-trial-sequential-analysis
#10
Florence Julien-Marsollier, Daphné Michelet, Myriam Bellon, Anne-Laure Horlin, Jean-Michel Devys, Souhayl Dahmani
BACKGROUND: Muscle relaxation for tracheal intubation during paediatric anaesthesia remains a subject of debate. OBJECTIVE: The aim of the current meta-analysis was to investigate the effect of muscle relaxants (MR) compared with opioids on intubation conditions in children. DESIGN: Meta-analysis of randomised controlled studies and GRADE analysis. DATA SOURCES: Exhaustive literature analysis. ELIGIBILITY CRITERIA: Clinical trials, with no high-risk bias, that examined the effect of MR in comparison with opioids on intubation conditions (excellent: primary outcome, acceptable: secondary outcome) in children were included...
February 17, 2017: European Journal of Anaesthesiology
https://www.readbyqxmd.com/read/28220604/a-mobile-health-intervention-promoting-healthy-gestational-weight-gain-for-women-entering-pregnancy-at-a-high-body-mass-index-the-txt4two-pilot-randomised-controlled-trial
#11
J C Willcox, S A Wilkinson, M Lappas, K Ball, D Crawford, E A McCarthy, B Fjeldsoe, R Whittaker, R Maddison, K J Campbell
OBJECTIVE: To determine the feasibility and effectiveness of an mHealth intervention promoting healthy diet, physical activity and gestational weight gain in pregnant women. DESIGN: Randomised controlled trial (RCT). SETTING: Australian tertiary obstetric hospital. POPULATION: One hundred pregnant women who were overweight or obese prior to pregnancy. METHODS: Women recruited at the first antenatal clinic visit were randomised to either an intervention or a control group...
February 20, 2017: BJOG: An International Journal of Obstetrics and Gynaecology
https://www.readbyqxmd.com/read/28220521/indirect-treatment-comparison-itc-of-medical-therapies-for-an-overactive-bladder
#12
Aneta Obloza, Joshua Kirby, Derrick Yates, Philip Toozs-Hobson
BACKGROUND: Overactive bladder syndrome (OAB) is a chronic and prevalent condition which has a negative impact on Quality of Life. The National Institute of Clinical Excellence issued two documents which give slightly varying algorithms of pharmacotherapy for OAB, offering mirabegron as a possible treatment in certain circumstances. In the absence of trials involving a direct comparison of therapies, an indirect comparison can provide useful information on the difference in treatment effects between competing interventions...
February 21, 2017: Neurourology and Urodynamics
https://www.readbyqxmd.com/read/28220514/randomised-clinical-trial-faecal-microbiota-transplantation-for-recurrent-clostridum-difficile-infection-fresh-or-frozen-or-lyophilised-microbiota-from-a-small-pool-of-healthy-donors-delivered-by-colonoscopy
#13
Z D Jiang, N J Ajami, J F Petrosino, G Jun, C L Hanis, M Shah, L Hochman, V Ankoma-Sey, A W DuPont, M C Wong, A Alexander, S Ke, H L DuPont
BACKGROUND: Faecal microbiota transplantation (FMT) has become routine in managing recurrent C. difficile infection (CDI) refractory to antibiotics. AIM: To compare clinical response and improvements in colonic microbiota diversity in subjects with recurrent CDI using different donor product. METHODS: Seventy-two subjects with ≥3 bouts of CDI were randomised in a double-blind study to receive fresh, frozen or lyophilised FMT product via colonoscopy from 50 g of stool per treatment from eight healthy donors...
February 21, 2017: Alimentary Pharmacology & Therapeutics
https://www.readbyqxmd.com/read/28220474/buprenorphine-for-managing-opioid-withdrawal
#14
REVIEW
Linda Gowing, Robert Ali, Jason M White, Dalitso Mbewe
BACKGROUND: Managed withdrawal is a necessary step prior to drug-free treatment or as the endpoint of substitution treatment. OBJECTIVES: To assess the effects of buprenorphine versus tapered doses of methadone, alpha2-adrenergic agonists, symptomatic medications or placebo, or different buprenorphine regimens for managing opioid withdrawal, in terms of the intensity of the withdrawal syndrome experienced, duration and completion of treatment, and adverse effects...
February 21, 2017: Cochrane Database of Systematic Reviews
https://www.readbyqxmd.com/read/28220472/renal-denervation-for-resistant-hypertension
#15
REVIEW
Giuseppe Coppolino, Anna Pisano, Laura Rivoli, Davide Bolignano
BACKGROUND: Resistant hypertension is highly prevalent among the general hypertensive population and the clinical management of this condition remains problematic. Different approaches, including a more intensified antihypertensive therapy, lifestyle modifications, or both, have largely failed to improve patients' outcomes and to reduce cardiovascular and renal risk. As renal sympathetic hyperactivity is a major driver of resistant hypertension, renal sympathetic ablation (renal denervation) has been recently proposed as a possible therapeutic alternative to treat this condition...
February 21, 2017: Cochrane Database of Systematic Reviews
https://www.readbyqxmd.com/read/28219961/protocol-for-the-development-of-a-core-domain-set-for-hidradenitis-suppurativa-trial-outcomes
#16
Linnea Thorlacius, John R Ingram, Amit Garg, Bente Villumsen, Solveig Esmann, Joslyn S Kirby, Alice B Gottlieb, Joseph F Merola, Robert Dellavalle, Robin Christensen, Gregor B E Jemec
INTRODUCTION: Randomised controlled trials (RCTs) should have well-defined primary and secondary outcomes to answer questions generated by the main hypotheses. However, for the chronic, inflammatory skin disease hidradenitis suppurativa (HS), the reported outcome measures are numerous and diverse. A recent systematic review found a total of 30 outcome measure instruments in 12 RCTs. This use of a broad range of outcome measures can increase difficulties in interpretation and comparison of results and may potentially obstruct appropriate evidence synthesis by causing reporting bias...
February 20, 2017: BMJ Open
https://www.readbyqxmd.com/read/28219619/effect-of-availability-of-hiv-self-testing-on-hiv-testing-frequency-in-gay-and-bisexual-men-at-high-risk-of-infection-forth-a-waiting-list-randomised-controlled-trial
#17
Muhammad S Jamil, Garrett Prestage, Christopher K Fairley, Andrew E Grulich, Kirsty S Smith, Marcus Chen, Martin Holt, Anna M McNulty, Benjamin R Bavinton, Damian P Conway, Handan Wand, Phillip Keen, Jack Bradley, Johann Kolstee, Colin Batrouney, Darren Russell, Matthew Law, John M Kaldor, Rebecca J Guy
BACKGROUND: Frequent testing of individuals at high risk of HIV is central to current prevention strategies. We aimed to determine if HIV self-testing would increase frequency of testing in high-risk gay and bisexual men, with a particular focus on men who delayed testing or had never been tested before. METHODS: In this randomised trial, HIV-negative high-risk gay and bisexual men who reported condomless anal intercourse or more than five male sexual partners in the past 3 months were recruited at three clinical and two community-based sites in Australia...
February 16, 2017: Lancet HIV
https://www.readbyqxmd.com/read/28219612/hyperoxia-and-hypertonic-saline-in-patients-with-septic-shock-hypers2s-a-two-by-two-factorial-multicentre-randomised-clinical-trial
#18
Pierre Asfar, Frédérique Schortgen, Julie Boisramé-Helms, Julien Charpentier, Emmanuel Guérot, Bruno Megarbane, David Grimaldi, Fabien Grelon, Nadia Anguel, Sigismond Lasocki, Matthieu Henry-Lagarrigue, Frédéric Gonzalez, François Legay, Christophe Guitton, Maleka Schenck, Jean Marc Doise, Jérôme Devaquet, Thierry Van Der Linden, Delphine Chatellier, Jean Philippe Rigaud, Jean Dellamonica, Fabienne Tamion, Ferhat Meziani, Alain Mercat, Didier Dreyfuss, Valérie Seegers, Peter Radermacher
BACKGROUND: There is insufficient research into the use of mechanical ventilation with increased inspiratory oxygen concentration (FiO2) and fluid resuscitation with hypertonic saline solution in patients with septic shock. We tested whether these interventions are associated with reduced mortality. METHODS: This two-by-two factorial, multicentre, randomised, clinical trial (HYPERS2S) recruited patients aged 18 years and older with septic shock who were on mechanical ventilation from 22 centres in France...
February 14, 2017: Lancet Respiratory Medicine
https://www.readbyqxmd.com/read/28219477/autologous-incus-versus-titanium-partial-ossicular-replacement-prosthesis-in-reconstruction-of-austin-type-a-ossicular-defects-a-prospective-randomised-clinical-trial
#19
Amith Naragund, R S Mudhol
OBJECTIVE: This study aimed to compare the functional and anatomical outcomes of ossiculoplasty using an autograft incus or a titanium partial ossicular replacement prosthesis for reconstructing Austin type A ossicular defects. METHODS: Patients with Austin A ossicular defects were randomly divided into two groups: one group underwent ossiculoplasty with an autologous incus (the autologous incus group) and the other underwent ossiculoplasty with a titanium partial ossicular replacement prosthesis (the titanium prosthesis group)...
February 21, 2017: Journal of Laryngology and Otology
https://www.readbyqxmd.com/read/28219383/the-alice-springs-hospital-readmission-prevention-project-ashrapp-a-randomised-control-trial
#20
Gabrielle Diplock, James Ward, Simon Stewart, Paul Scuffham, Penny Stewart, Carole Reeve, Lea Davidson, Graeme Maguire
BACKGROUND: Hospitals are frequently faced with high levels of emergency department presentations and demand for inpatient care. An important contributing factor is the subset of patients with complex chronic diseases who have frequent and preventable exacerbations of their chronic diseases. Evidence suggests that some of these hospital readmissions can be prevented with appropriate transitional care. Whilst there is a growing body of evidence for transitional care processes in urban, non-indigenous settings, there is a paucity of information regarding rural and remote settings and, specifically, the indigenous context...
February 20, 2017: BMC Health Services Research
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